FDA Label for Simpex Guaifenesin
View Indications, Usage & Precautions
Simpex Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Simpex Pharma Pvt. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient (In Each Tablet)
Guaifenesin 400 mg
Purpose
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied with excessive phlegm (mucus)
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache.These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a poison control center right away.
Directions
- adults & children 12 years of age and older : take a tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
- children under 12 years of age : do not use.
Other Information
- preserve in tight containers at a temperature not exceeding 30°C.
Inactive Ingredients
colloidal anhydrous silica, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinised starch, sodium starch glycolate type A, stearic acid
Package Labeling:
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